NCT00794378已完成3 期
A Single-Center, Pediatric, Comparative Taste Test of Desloratadine and Cetirizine Antihistamine Syrup Medications
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 202
- 主要终点
- Taste acceptability as determined from smiley-face scale of 1 (frowning child) to 5 (happy child face).
研究概览
简要总结
This study was conducted to compare the taste acceptability of Zyrtec syrup with desloratadine syrup in children. Children between 6 and 11 years of age received 5 mL of each syrup, separated by 15 to 20 minutes on a single day.
详细描述
This study is a cross-over study design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be:
- •Between 6 and 11 years of age in good general health
- •Premenarcheal if female
排除标准
- •Subjects who:
- •Have known allergies or sensitivities to either of the drug formulations
- •Have a medical condition that may interfere with the subject's ability to discriminate between tastes
- •Have used any antihistamines within 24 hours prior to dosing
- •Were taking sedatives, tranquilizers, or monoamine oxidase inhibitor drugs
- •Were involved in another clinical or market research study within the past 30 days
研究组 & 干预措施
Desloratadine and Cetirizine Crossover
Experimental
To compare the preference in taste between desloratadine and cetirizine.
干预措施: Desloratadine (Clarinex) (Drug)
Desloratadine and Cetirizine Crossover
Experimental
To compare the preference in taste between desloratadine and cetirizine.
干预措施: Cetirizine (Zyrtec) (Drug)
结局指标
主要结局
Taste acceptability as determined from smiley-face scale of 1 (frowning child) to 5 (happy child face).
时间窗: During the only study visit
次要结局
- Taste flavor preference between bubble-gum, banana-grape, or grape flavors(During the only study visit)
- Adverse Events(During the only study visit)
研究者
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